MalfunctionEOQ
EVIS LUCERA ELITE BRONCHOVIDEOSCOPE
Received Jul 31, 2026 · Event occurred Jul 8, 2026
Report 9610595-2026-61787 · MDR key 50097889
Device
Product problems
- Peeled/Delaminated
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the distal end coating peeled off the scope. The issue was found during maintenance. No harm reported.
Additional Manufacturer Narrative
E1: (b)(6). The investigation is ongoing. A supplemental report will be submitted when the investigation is completed or if additional information becomes available.